Commonly owned WIPO International Application No. PCT/IL2006/001228 entitled Needleless Additive Control Valve and published under WIPO International Publication No. WO 2007/052252 is intended for use with infusion liquid containers containing an infusion liquid and having an intravenous (IV) or administration port. The infusion liquid containers can be in the form of an infusion liquid bag, an infusion liquid bottle, and the like. The needleless additive control valves are also intended for use with additive transfer devices including a male connector and containing a medicament additive. Suitable additive transfer devices include inter alia needleless syringes, male vial adapters, and the like. The needleless additive control valves are also intended for use with infusion sets with an IV spike and a connector for administration purposes to a patient.
The needleless additive control valves include a trifurcated connector body including an IV spike for sealing insertion into an IV port of an infusion liquid container, a normally closed (NC) needleless additive port with a female connector, and a substitute IV port. The IV spike has a single lumen, the NC needleless additive port has a single lumen and the substitute IV port has a single lumen. The three lumens are in 3 way direct and continuous fluid connection. The substitute IV port is formed from suitable flexible plastic material, for example, PVC, and the like, for sealingly receiving an IV spike of an infusion set. The substitute IV spike includes a membrane intended to be punctured on insertion of the IV spike of the infusion set.
In one embodiment of the needleless additive control valve, the NC needleless additive port is constituted by a self-sealing access valve with a swabbable exposed surface for enabling multiple additions of medicament additives. Suitable self-sealing access valves are disclosed in inter alia U.S. Pat. No. 5,676,346 to Leinsing. Multiple additions can be in relative quick succession to introduce a greater quantity of additive than available in a single addition. Alternatively, multiple additions can be over the course of several hours depending on the medical condition of a patient. In another embodiment of the needleless additive control valve, the NC needleless additive port is constituted by a manually operated stop cock, and the like.
WO 2007/052252 FIGS. 4A and 4B show the use of the needleless additive control valve with a needleless syringe for enabling injection of the syringe contents either into an infusion liquid container to form a medicated infusion liquid or direct administration to a patient.
WO 2007/052252 FIGS. 5A and 5B show the use of the needleless additive control valve with a vial adapter and a vial for enabling mixing of vial contents with infusion liquid contents to form a medicated infusion liquid by passing infusion liquid from the infusion liquid container into the vial and vice versa one or more times.
The needleless additive control valves with a self-sealing access valve are now commercially available from West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, Pa. 19341 www.westpharma.com under the registered trademark VIAL2BAG. The needleless additive control valves have found widespread usage for bedside preparation of infusion liquid containers as opposed to the previous widespread practice of preparing such infusion liquid containers in compound pharmacies. Moreover, the needleless additive control valves have found more widespread use with vials as opposed to syringes.